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Details for New Drug Application (NDA): 020392

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NDA 020392 describes CYSTAGON, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTAGON profile page.

The generic ingredient in CYSTAGON is cysteamine bitartrate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.

Summary for NDA: 020392

Tradename:
CYSTAGON
Applicant:
Mylan
Ingredient:
cysteamine bitartrate
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details

Pharmacology for NDA: 020392

Mechanism of ActionCystine Disulfide Reduction

Suppliers and Packaging for NDA: 020392

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTAGON
cysteamine bitartrate
CAPSULE;ORAL 020392 NDA Mylan Pharmaceuticals Inc. 0378-9040 0378-9040-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-01)
CYSTAGON
cysteamine bitartrate
CAPSULE;ORAL 020392 NDA Mylan Pharmaceuticals Inc. 0378-9040 0378-9040-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 15, 1994TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 15, 1994TE:RLD:Yes


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